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Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

20. juli 2015 opdateret af: Merck Sharp & Dohme LLC

Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Non-Probability Sample, Commercial product used according to EU label.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

99

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with chronic HCV.

Beskrivelse

Inclusion Criteria:

  • According to PegIntron/Rebetol label.
  • Only HCV genotype 1 infected patients will be enrolled in the study.

Exclusion Criteria:

  • According to PegIntron/Rebetol label.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Treatment and Patient Assistance Program
Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
Biologisk: PegIntron (peginterferon alfa-2b; SCH 54031)
Peginterferon alfa-2b will be administered according to the product's labeling.
Andre navne:
  • PegIntron
Medicin: Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Andre navne:
  • Rebetol
Adfærdsmæssigt: Patient Assistance Program

The patient assistance program includes the following:

  • Training by physicians or specialized nurses.
  • Informational materials based on the "To beat HCV" program.
  • Management of specific side effects.
Andre navne:
  • Support program
Treatment Alone
PegIntron/Rebetol treatment only.
Biologisk: PegIntron (peginterferon alfa-2b; SCH 54031)
Peginterferon alfa-2b will be administered according to the product's labeling.
Andre navne:
  • PegIntron
Medicin: Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.
Andre navne:
  • Rebetol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
Tidsramme: At the end of the 48-week treatment period
Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program
At the end of the 48-week treatment period
The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment
Tidsramme: Measured at 6 months post-treatment
Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment
Measured at 6 months post-treatment
The Number of Participants Who Relapsed at 6 Months Post-treatment
Tidsramme: Measured at end of treatment and 6 months post-treatment
Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment
Measured at end of treatment and 6 months post-treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average Length of Treatment
Tidsramme: Maximum 48-week treatment duration
Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.
Maximum 48-week treatment duration
Average Dosage of PegIntron
Tidsramme: Up to 48-week treatment duration
Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week
Up to 48-week treatment duration
Average Dosage of Rebetol
Tidsramme: Up to 48-week treatment duration
Rebetol dosage was expressed in milligrams per kilogram of body weight per day.
Up to 48-week treatment duration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2005

Primær færdiggørelse (Faktiske)

1. december 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

31. juli 2008

Først indsendt, der opfyldte QC-kriterier

31. juli 2008

Først opslået (Skøn)

5. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P04671

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatitis C

Kliniske forsøg med PegIntron (peginterferon alfa-2b; SCH 54031)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ecuador

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner